- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
- On Thursday, July 22 the FDA issued an Emergency Use Authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing. The device authorized under this EUA is for use in coagulation testing, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients, including patients with known or suspected COVID-19.The FDA also posted frequently asked questions (FAQs) about sodium citrate blood specimen collection tubes. For details on the EUA, see the letter of authorization.
- A new FDA Voices, Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines, describes efforts being made to address inadequacies in research through a paradigm shift in the approach to studying medical products in pregnant and breastfeeding women.
- As part of the FDA’s effort to protect consumers, on Tuesday, July 20 the agency issued a warning letter to Jordan’s Crossing Herbal Connections for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 395 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 279 molecular tests and sample collection devices, 86 antibody and other immune response tests and 30 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 586 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn